Valved catheter

ABSTRACT

A valved catheter is provided which includes a slit that opens readily in both directions either when a fluid is caused to flow from the interior to the exterior thereof or when a fluid is caused to flow from the exterior to the interior thereof, and that prevents inadvertent closure thereof from the opened state. The valve includes an openable slit that penetrates from the inner surface to the outer surface of a distal end section of a valved catheter with a closed distal end, and edge portions on the two sides of the slit are formed along the direction in which the valved catheter extends. The slit includes a linear shape in the cross-section of the distal end section of the valved catheter that extends in a position away from a center line “c” that passes through the center of the valved catheter in parallel with this center line “c” whereupon, either one of the edge portions deforms more readily than either one of the other edge portions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. §119 to Japanese PatentApplication Serial No. 2009-199639, filed Aug. 31, 2009, the entirecontents of which are incorporated by reference in their entirety.

TECHNICAL FIELD

The present disclosure relates to a valved catheter through which afluid is able to pass from the interior to the exterior thereof, andfrom the exterior to the interior thereof, by way of a valve including aslit.

DESCRIPTION OF RELATED ART

The temporary and long-term delivery of medical fluids, includinganti-cancer agents and nutrients, into the vein of a patientconventionally involves, for example, the placement of a catheter in thebody of the patient. Stable injection of medical fluids employing suchcatheters necessitates the avoidance of catheter blockage while themedical fluid is being injected. However, when catheters with an opendistal end are employed, blood is able to infiltrate into the catheterwhere it coagulates and causes the blockage thereof. While catheterblockage by blood is commonly prevented by filling the lumen of thecatheter with a heparin-added physiological saline solution or the like,this renders the operation pertaining to the placement of the catheterin the body of the patient more troublesome and, moreover, increases theburden on the medical practitioner and the patient.

To that end, a valved catheter that prevents catheter blockage caused bycoagulated blood using a design based on the elimination of the openeddistal end and the provision of a valve that is normally closed andopens only when a medical fluid or blood is being extracted between theinterior and the exterior of the catheter has been developed (see, forexample, U.S. Pat. No. 7,413,564). In this slit valve catheter (valvedcatheter), an elongate recessed portion is formed along the longitudinaldirection thereof, and a slit is formed in the center of this recessedportion along the longitudinal direction of the recessed portion.

The slit of this slit valve catheter is designed to open both inward andoutward by a comparatively small pressure and, when a predeterminedpressure differential is generated between the interior and exterior ofthe slit valve catheter, the slit valve opens to facilitate either theinjection of a medical fluid into a vein or the extraction of blood froma vein through the catheter. In addition, this slit is closed in theabsence of the generation of this predetermined pressure differentialbetween the interior and exterior of the slit valve catheter and,accordingly, blood coagulation within the slit is prevented.

However, in the conventional valved catheter described above, theopposing surfaces of, the edge portions of the two sides of the slit ofthe valve catheter are in intimate contact, and simultaneously deformwhile retaining their symmetrical shape when the slit opens and closes.For this reason, the slit is less readily able to be opened from theclosed state at low fluid pressure due to the pressure contact betweenthese opposing surfaces, and is less readily able to be closed from theopened state.

SUMMARY

With the foregoing conditions in mind, it is an object of the presentdisclosure to provide a valved catheter that includes a slit that opensreadily in both directions when either a fluid is caused to flow fromthe interior to the exterior thereof or when a fluid is caused to flowfrom the exterior to the interior thereof; and that prevents inadvertentclosure thereof from the opened state.

A characterizing feature of the constitution of the valved catheterpertaining to the present disclosure for achieving this object residesin a resilient and flexible valved catheter which is made from a resinand which is formed in a tube shape with a closed distal end and inwhich a valve including an openable slit that penetrates from the innersurface to the outer surface is formed along the longitudinal directionin this distal end section, a first edge portion of the edge portions ofthe two sides of the slit of the valve being deformed more readily thanthe other edge portion when either a fluid is caused to flow from theinterior to the exterior by way of the valve, or when a fluid is causedto flow from the exterior to the interior by way of the valve.

In the valved catheter of the present disclosure of the constitutiondescribed above, a first edge portion of the edge portions of the twosides of the slit of the valve including a slit is deformed more readilyby the pressure of a fluid than the other edge portion. Accordingly, thetwo edge portions of the slit do not deform simultaneously and, instead,the slit is opened slightly due to the initial deformation of the firstedge portion, and is subsequently opened sufficiently to allow fluid topass therethrough due to the force that is generated by the flow offluid. In addition, even if the other edge portion is deformed in adirection for closing the slit from the opened slit state, because thefirst edge portion does not deform simultaneously with the other edgeportion and a state that allows the flow of fluid to occur is able to hemaintained, the slit closes gradually as the fluid pressure drops and asthe first edge portion approaches the other edge portion.

In this case, the first edge portion that deforms more readily and theother edge portion that deforms less readily than the first edge portionare interchangeable in accordance with whether the fluid is passing fromthe interior to the exterior of the circular tube-shaped body or if thefluid is passing from the exterior to the interior of the circulartube-shaped body. Accordingly, the slit opens readily not only whenfluid flows from the interior to the exterior of the valved catheter butalso when fluid flows from the exterior to the interior of the valvedcatheter and, as a result, the bidirectional inward and outward flow offluid therethrough is able to be effected smoothly. In addition, whenlittle or no pressure differential exists between the interior and theexterior of the valved catheter, the closed state of the slit ismaintained.

Notably, the term fluid referred to in the present disclosure describesfluids that are injected into the vein of a patient such as medicalfluids, including anti-cancer agents and nutrients, and fluids that areextracted from the vein, including blood. The fluid that flows from theinterior to the exterior of the valved catheter shall be hereinafterreferred to as a medical fluid, while the fluid that flows from theexterior to the interior of the valved catheter shall be hereinafterreferred to as blood. In addition, the cross-sectional shape of thetube-shaped valved catheter may be circular or elliptical, or a range ofshapes similar thereto.

Another characterizing feature of the valved catheter pertaining to thepresent disclosure resides in the shape of the adjoining sections of theslit in the cross-section orthogonal to the longitudinal direction ofthe distal end section of the valved catheter being described by theasymmetry of the edge portions of the two sides about the slit.

The asymmetry of the edge portions of the two sides about the slitdescribed herein refers to a relationship whereby, bending thecross-sectional shape of the valved catheter about the slit, theadjoining sections to the two edge portions of the slit do not overlapperfectly. For example, for a valved catheter of a circularcross-sectional shape, the slit describes a linear shape in thecross-section of the valved catheter, and is located in a position awayfrom an imaginary straight line (where it does not overlap thisimaginary straight line) passing through the center of the valvedcatheter. In addition, for a valved catheter of an ellipticalcross-sectional shape, the slit describes a linear shape in thecross-section of the valved catheter, and is located in a position awayfrom the directions in which the long axis and short axis thereofpassing through the center of the valved catheter extend.

Accordingly, because the shape of the adjoining sections to the edgeportions of the two sides of the slit is always asymmetrical about theslit, either one of the edge portions is able to be more readilydeformed than the other edge portion by the pressure exerted thereon bythe medical fluid. In addition, once the slit is open, the slit does notclose until the fluid pressure drops and the more readily deformableedge portion approaches the other edge portion and, accordingly, theslit closes gradually and the inadvertent closure thereof is prevented.

A further characterizing feature of the valved catheter pertaining tothe present disclosure resides in the valved catheter being formed in atube shape with a circular cross-section, the slit describing a linearshape in the cross-section in a position away from an imaginary straightline passing through the center of the valved catheter and extending inparallel with the imaginary straight line and, taking a minimum distancefrom the imaginary straight line to the slit as “a,” and a distanceequivalent to “a” subtracted from ½ of the inner diameter of thecircular tube-shaped shaped body as “b,” “a” being greater than “b.”

Accordingly, when a medical fluid is caused to flow from the interior tothe exterior of the valved catheter, the slit opens readily as a resultof the pressure exerted thereon by the medical fluid in such a way thatthe edge portion of the edge portions of the two sides of the slit ofthe side away from the imaginary straight line separates outward withrespect to the edge portion on the imaginary straight line side. Inaddition, when blood flows from the exterior to the interior of thevalved catheter, the slit opens readily as a result of the pressure thatis exerted thereof by the blood in such a way that the edge portion ofthe edge portions of the two sides of the slit of the imaginary straightline side separates inwardly with respect to the edge portion of theside away from the imaginary straight line. In addition, once the slitis open, because the slit does not close until the fluid pressure dropsand the more readily deformable edge portion approaches the other edgeportion, the slit closes gradually and the inadvertent closure thereofis able to be prevented. Furthermore, the valved catheter produced inaccordance with the present disclosure is ideal in terms of thesuitability of the ease of opening thereof, and in being able to closegradually in response to the drop in fluid pressure when closing from anopened state.

Another characterizing feature of the constitution of the valvedcatheter of the present disclosure resides in the edge portions of thetwo sides of the slit of the valve being constituted by resins ofdifferent hardness.

Accordingly, because the hardness of the first edge portion of the edgeportions of the two sides of the slit is less than the hardness of theother edge portion, the first edge portion of the slit is more readilydeformable than the other edge portion. For this reason, when a medicalfluid flows from the interior to the exterior of the valved catheter,the slit opens readily due to the pressure that is exerted thereon bythe medical fluid in such a way that the first edge portion of the twoedge portions of the slit separates outwardly with respect to the otheredge portion, and when blood flows from the exterior to the interior ofthe valved catheter, the slit opens readily due to the pressure that isexerted thereon by the blood in such a way that the first edge portionof the two edge portions of the slit separates inwardly with respect tothe other edge portion. That is to say, the slit opens readily wheneither a medical fluid is caused to flow from the interior to theexterior of the valved catheter or when blood is caused to flow from theexterior to the interior thereof, and inadvertent closure from theopened state thereof is prevented. The resins employed in this case maybe resins of different types, or they may be identical resins ofdifferent hardness.

An additional characterizing feature of the constitution of the valvedcatheter pertaining to the present disclosure resides in acontrast-imparting material of greater hardness than the resin beingincorporated into the other edge portion of the slit of the valve.

Accordingly, when the valved catheter is positioned within the body, theslit is able to be readily opened using the contrast-imparting materialthereof as a means for confirming the position of the valved catheter.That is to say, because the contrast-imparting material is normallyconstituted of barium or tungsten which is harder than the resin, theincorporation of this contrast-imparting material in the other edgeportion of the slit ensures that the hardness of the other edge portionis greater than the hardness of the first edge portion of this slit. Asa result, when either a medical fluid is caused to flow from theinterior to the exterior of the valved catheter or when blood is causedto flow from the exterior to the interior, the slit is able to be morereadily opened, and inadvertent closure from the opened state is able tobe prevented. In this case, the contrast-imparting material may beincorporated in the other edge portion as a powder, or it may beincorporated in the other edge portion as fibers.

An additional characterizing feature of the constitution of the valvedcatheter pertaining to the present disclosure resides in the thicknessof the first edge portion of the slit of the valve being thinner thanthe other edge portion. Accordingly, when either a medical fluid iscaused to flow from the interior to the exterior of the valved catheteror when blood is caused to flow from the exterior to the interior of thevalved catheter, the slit is able to be more readily opened, andinadvertent closure thereof from the opened state is able to beprevented.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1B show a valved catheter of a first embodiment of the presentdisclosure of which, FIG. 1A is a side view and FIG. 1B is a rear viewthereof;

FIG. 2 is a cross-sectional view taken along the line 2-2 of FIG. 1A;

FIG. 3 is an explanatory diagram of the valved catheter when placed inthe body of a patient;

FIGS. 4A-4B show a distal end section of a valved catheter of a secondembodiment of the present disclosure of which, FIG. 4A is a side viewand FIG. 4B is a rear view thereof;

FIG. 5 is a cross-sectional view taken along the line 5-5 of FIG. 4A;

FIGS. 6A-6B show a distal end section of a valved catheter of a thirdembodiment of the present disclosure of which, FIG. 6A is a side viewand FIG. 6B is a rear view thereof;

FIG. 7 is a cross-sectional view taken along the line 7-7 of FIG. 6A;

FIG. 8 is a cross-sectional view of a distal end section of a valvedcatheter of a fourth embodiment of the present disclosure;

FIG. 9 is a cross-sectional view of a distal end section of a valvedcatheter of a modified example of the fourth embodiment;

FIG. 10 is a cross-sectional view of a distal end section of a valvedcatheter of a fifth embodiment of the present disclosure; and

FIG. 11 is a cross-sectional view of a distal end section of a valvedcatheter of a modified example of the fifth embodiment.

DESCRIPTION OF THE EMBODIMENTS

A first embodiment of the valved catheter pertaining to the presentdisclosure will be hereinafter described in detail with reference to thedrawings. FIGS. 1A-1B and FIG. 2 show a valved catheter 10 of thisembodiment. The valved catheter 10, which is used for delivering amedical fluid such as an anticancer agent or nutrients into a vein(reference characters B1 to B3 and so on as shown in FIG. 3) of apatient A, is placed in the patient A by the connection of a port 17 toa proximal end portion 11 thereof. The valved catheter 10, which isconstituted by an elongate, circular tube-shaped body composed of a softpolyurethane resin, is resilient and flexible.

In addition, a dome-shaped wall portion 12 is formed in the distal endof the valved catheter 10, and the distal end of the valved catheter 10is closed by this wall portion 12. The wall portion 12, which iscomposed of silicon or polyurethane that is softer than the main body ofthe valved catheter 10, is fastened to the main body of the valvedcatheter 10 by adhesion or fusion. An elongate valve 13 that extendsalong the axial direction (longitudinal direction) of the valvedcatheter 10 is formed in a section of the circumferential surfaceportion of the valved catheter 10 more towards the proximal end portion11 side than the wall portion 12.

The valve 13 is constituted by a linear slit 14 that extends along theaxial direction of the valved catheter 10, and by edge portions 15, 16formed in the two sides of the slit 14 (two sides around thecircumference thereof). The slit 14 penetrates from the innercircumferential surface to the outer circumferential surface of thevalved catheter 10 and, as shown in FIG. 2, is formed in parallel withan imaginary straight line drawn as the center line “c” of the presentdisclosure. In addition, taking a tangent line that touches the innercircumferential surface of the valved catheter 10 and that runs parallelto the center line “c” as “d,” a length “a” from the center line “c” tothe slit 14 is set longer than a length “b” from the tangent line “d” tothe slit 14. In this case, the length of “a” is set so as to beapproximately twice the length of the length “b.” The edge portion 15 isconstituted by the adjoining section of the edge portion on the centerline “c” side of the slit 14, and the edge portion 16 is constituted bythe adjoining section of the edge portion on the tangent line “d” sideof the slit 14.

The slit 14 opens as a result of the deformation of the edge portions15, 16 when the pressure exerted orthogonally on the inner surface andthe outer surface of the valve 13 reaches, for example, at least 50 to60 cm H₂0. In this case, when a positive pressure is exerted on theinner surface of the valved catheter 10 and a negative pressure isexerted on its outer surface, the slit 14 opens initially as a result ofthe edge portion 16 being pressured outwardly away from the edge portion15. In addition, when a positive pressure is exerted on the outersurface of the valved catheter 10 and a negative pressure is exerted onits inner surface, the slit 14 opens as a result of the edge portion 15being pressured inwardly away from the edge portion 16. In the absenceof any pressure being exerted on the valve 13, or when the pressureexerted thereon is less than a predetermined value, the resilience ofthe valve 13 ensures intimate contact between the opposing surfaces ofthe edge portions 15, 16 from which the slit 14 is formed and,accordingly, ensures closure of the slit 14.

When the valved catheter 10 of this constitution is employed to delivera medical fluid into the vein of a patient A, the port 17 is initiallyconnected to the proximal end portion 11 of the valved catheter 10. Theport 17, which is constituted by fastening a septum 19 to the uppersurface of a circular plate-shaped main body 18, includes a spaceportion (not shown in the drawing) formed in its interior. The septum 19is constituted of a material through which a needle is able to beinserted that possesses a property whereby, upon removal of the needle,the hole created by the insertion of the needle closes up. Accordingly,when the needle of a syringe filled with a medical fluid is inserted inthe septum 19 of the port 17 and a medical fluid is injected through thesyringe into the port 17, the medical fluid is able to pass from thespace portion of the port 17 through the interior of the valved catheter10 and flow outwardly therefrom through the slit 14.

As shown in FIG. 3, the valved catheter 10 to which the port 17 isconnected is able to be inserted through a chest portion C of thepatient A into a vein, or is able to be inserted through an arm portionD of the patient A into a vein. When the valved catheter 10 to which theport 17 is connected is to be inserted through the chest portion C intothe vein, an incision is made in the adjoining section of a vein of thechest portion C such as, for example, the subclavian vein B1, whereuponthe valved catheter 10 is inserted through the subclavian vein B1located in proximity to this section, and the distal end section thereofis then passed through to a superior caval vein B2. The port 17 is thensubcutaneously embedded in the chest portion.

In addition, when the valved catheter 10 to which the port 17 isconnected is to be inserted through the arm portion D into the vein, anincision is made in the upper arm section of the arm portion D,whereupon the valved catheter 10 is inserted through a brachial vein B3located in proximity thereto and its distal end section is then passedfrom the brachial vein B1 through to the superior caval vein B2. Theport 17 is then subcutaneously embedded in the chest portion. In bothcases, a state in which the interior portion between the valved catheter10 and the port 17 is filled with a physiological saline solution isestablished. Accordingly, the inward pressure of the valved catheter 10is essentially the same as the outward pressure thereof and, as aresult, the closed state of the slit 14 is able to be maintained.

When a medical fluid is to be delivered to the vein of the patient A byway of the valved catheter 10 to which the port 17 is connected, theneedle of the syringe filled with the medical fluid is first insertedthrough the surface of the skin and passed through the septum 19, andthe tip of the needle is then positioned in the interior of the port 17.The medical fluid is injected from the syringe into the port 17. As aresult, the medical fluid is caused to pass from the interior of theport 17 through the interior of the valved catheter 10, and issubsequently introduced into the superior caval vein B2 through the slit14. When the pressure exerted on the medical fluid from the syringe isgreater than the pressure of the blood within the superior caval veinB2, the edge portions 15, 16 of the valve 13 deform outwardly from thevalved catheter 10 and the slit 14 opens. In this case, the slit 14 isinitially caused to open due to the deformation of the edge portion 16outward, whereupon the edge portion 15 is then deformed, and the slit 14is caused to open further, due to the force that is subsequentlygenerated by the flow of the medical fluid.

Moreover, processes pertaining to blood extraction and confirmation ofblood reflux include the needle of the syringe in a vacuum state beinginserted through the surface of the skin and passed through the septum19. When the tip of the syringe is positioned in the interior of theport 17, the plunger of the syringe is pulled. As a result, the blood inthe vein passes from the superior caval vein B2 through the slit 14 intothe interior of the valved catheter 10. At this time, the slit 14 iscaused to open toward the interior of the valved catheter 10 as a resultof deformation of the edge portions 15, 16 of the valve 13 generated bythe suction force of the syringe. In this case, the slit 14 is caused toopen initially due to inward deformation of the edge portion 15, and theedge portion 16 then deforms, and the slit 14 is caused to open further,due to the force subsequently generated by the flow of the medicalfluid. At this time, the edge portion 16 deforms outward.

Accordingly, when a medical fluid is delivered through the valvedcatheter 10 into a vein or when blood from a vein is suctioned into theinterior of the valved catheter 10, the slit 14 is able to open readilyand the medical fluid or blood is able to flow smoothly therethrough. Inaddition, when the pressure of the medical fluid or blood drops, theslit 14 does not close immediately and instead closes gradually inaccordance with the drop in pressure. Furthermore, when no medical fluidis being injected and no blood is being suctioned using the syringe, theclosed state of the slit 14 is maintained due to the restoring force ofthe valve 13 afforded by the resilience thereof.

In the valved catheter 10 pertaining to this embodiment which includesthe valve 13 constituted by the slit 14 and the edge portions 15, 16located at the two sides of the slit 14 in this way, the slit 14 isformed in a linear shape in position away from the center line “c” ofthe valved catheter 10 in such a way as to extend in parallel with thecenter line “c.” Accordingly, when a medical fluid is delivered from thevalved catheter 10 into the vein, the edge portion 16 deforms morereadily than the edge portion 15 and, when the blood of a vein issuctioned into the interior of the valved catheter 10, the edge portion15 deforms more readily than the edge portion 16. As a result, the edgeportions 15, 16 do not open simultaneously and, instead, the slit 14opens slightly due to the initial deformation of either the edge portion16 or the edge portion 15, and the slit 14 then opens sufficiently toallow the medical fluid or blood to pass therethrough when the forcegenerated by the flow of medical fluid or blood is subsequently exertedthereon.

In addition, once the slit 14 is open, because the slit 14 does notclose until the fluid pressure drops and either the more readilydeforming edge portion 16 approaches the other edge portion 15 or themore readily deforming edge portion 15 approaches the other edge portion16, the slit 14 closes gradually and the rapid closure thereof isprevented. Accordingly, the slit 14 opens readily not only when amedical fluid flows from the interior to the exterior of the valvedcatheter 10 but also when blood flows from the exterior to the interiorthereof, and a smooth interior/exterior bidirectional flow of medicalfluid or blood is afforded thereby. In addition, because the distance“a” from the center line “c” to the slit 14 is longer than the distance“b” from the tangent line “d” to the slit 14, the production of an idealslit 14 in terms of both the suitability of the ease of opening thereofand being able to close gradually in response to the drop in fluidpressure when closing from an opened state is afforded thereby.

FIG. 4 and FIG. 5 show a valved catheter 20 pertaining to a secondembodiment of the present disclosure. Similarly to the valved catheter10 described above, the valved catheter 20 has an open proximal endportion 21 and a dome-shaped wall portion 22 formed in its distal end. Avalve 23 of this embodiment is constituted by a linear slit 24 providedto extend in the axial direction of the valved catheter 20, and by edgeportions 25, 26 formed in the two sides of the slit 24 in thecircumferential direction. The slit 24 is formed in such a way as to lieon an imaginary straight line (not shown in the drawing) passing througha center point in the cross-section of the valved catheter 20 shown inFIG. 5.

In addition, while the resin material from which the edge portion 25 isconstituted is a polyurethane of the same type as the other sectionsfrom which the valved catheter 20 is constituted, this polyurethane issofter than the polyurethane from which the other sections areconstituted, and the sections composed of this soft resin materialinclude the edge portion 25 section adjacent to the slit 24 and sectionsthat extend along the front side and rear side of the edge portion 25.That is to say, the edge portion 25 is constituted from a soft sectionin the section that extends from the proximal end to the distal endsection of the valved catheter 10 excluding the wall portion 22, and thesection thereof adjacent to the slit 24. The constitution of the othersections of the valved catheter 20 is identical to the constitution ofthe other sections of the valved catheter 10 of the first embodimentdescribed above.

The operations performed employing the valved catheter 20 to deliver amedical fluid into the vein of a patient A or to suction blood from avein are identical to the operations performed employing the valvedcatheter 10 as described above to deliver a medical fluid into the veinof a patient A or suctioning blood from a vein. Accordingly, when eithera medical fluid is caused to flow from the interior to the exterior ofthe valved catheter 20 or when blood is caused to flow from the exteriorto the interior thereof, the edge portion 25 responds more sensitivelyto changes in fluid pressure than the edge portion 26 and, in turn,deforms more readily than the latter. The remaining action and effectsof the valved catheter 20 are identical to the action and effectsafforded by the valved catheter 10.

FIG. 6 and FIG. 7 show a valved catheter 30 pertaining to a thirdembodiment of the present disclosure. Similarly to the valved catheter10, the valved catheter 30 includes an open proximal end portion 31 andhas a dome-shaped wall portion 32 formed in its distal end. A valve 33thereof is constituted by a linear slit 34 provided to extend in theaxial direction of the valved catheter 30, edge portions 35, 36 formedin the two sides of the slit 34 in the circumferential direction, and acontrast-imparted portion 37 formed in the interior of the edge portion35. The slit 34 is formed in such a way as to lie on an imaginarystraight line (not shown in the drawing) passing through a center pointin the cross-section of the valved catheter 30 shown in FIG. 7.

In addition, the contrast-imparted portion 37, which is constituted byadmixing a polyurethane resin with a contrast-imparting materialcomposed of a barium or tungsten powder or the like of greater hardnessthan the polyurethane resin, is formed in parallel with the slit 34 in asection adjacent to the slit 34. The contrast-imparted portion 37prevents the transmission of X-rays therethrough and, accordingly, whenirradiated with X-rays, a shadow is formed and a contrast with the othersections is created thereby. This contrast affords confirmation of theposition of the distal end section of the valved catheter 30 when it isplaced in the body. The constitution of the other sections of the valvedcatheter 30 is identical to the constitution of the valved catheter 10of the first embodiment described above.

The operations performed employing the valved catheter 30 to deliver amedical fluid into the vein of a patient A or to suction blood from avein are identical to the operations performed employing the valvedcatheter 10 as described above to deliver a medical fluid into the veinof a patient A or to suction blood from a vein. Accordingly, because theedge portion 35 is made less readily deformable than the edge portion 36by the provision of the contrast-imparted portion 37, when either amedical fluid is caused to flow from the interior to the exterior of thevalved catheter 30 or when blood is caused to flow from the exterior tothe interior thereof, the edge portion 36 responds more sensitively tochanges in fluid pressure than the edge portion 35 and, in turn, deformsmore readily than the latter. Furthermore, a contrast is producedbetween the contrast-imparted portion 37 and the other sections whenthey are irradiated with X-rays, and therefore it is possible to confirmthe position of the distal end section of the valved catheter 30 insidethe body. The remaining action and effects of the valved catheter 30 areidentical to the action and effects of the valved catheter 10.

FIG. 8 shows a cross-section of the distal end section of the valvedcatheter 40 pertaining to a fourth embodiment of the present disclosure.The valve 43 of this valved catheter 40 is constituted by a linear slit44 provided to extend along the axial direction (the directionorthogonal to the plane of the paper of FIG. 8) of the valved catheter40, and by edge portions 45, 46 formed in the two sides of thecircumferential direction of the slit 44. The edge portion 46 is formedthinner than the edge portion 45 due to the formation of an inclinedface in the outer circumferential side of a section adjacent to the slit44 of the valved catheter 40 that thins gradually toward the slit 44side. While there is no hard section and no contrast-imparted portionprovided in the valved catheter 40, the constitution of the othersections of the valved catheter 40 is identical to the constitution ofthe valved catheters 20, 30 described above.

The operations performed employing the valved catheter 40 to deliver amedical fluid into the vein of a patient A or to suction blood from avein are identical to the operations performed when employing the valvedcatheter 10 as described above to deliver a medical fluid into the veinof a patient A or to suction blood from a vein. Accordingly, the edgeportion 46 is formed thinner than the edge portion 45 and, as a result,deforms more readily than the latter. As a result, when either a medicalfluid flows from the interior to the exterior of the valved catheter 40or when blood flows from the exterior to the interior thereof, the edgeportion 46 deforms prior to the edge portion 45 and the slit 44 opensreadily. The other action and effects of the valved catheter 40 areidentical to the action and effects of the valved catheter 10 describedabove.

FIG. 9 shows a cross-section of a distal end section of a valvedcatheter 40 a pertaining to a modified example of the fourth embodimentof the present disclosure. A valve 43 a of this valved catheter 40 a isconstituted by a linear slit 44 a provided to extend along the axialdirection of the valved catheter 40 a, and by edge portions 45 a, 46 aformed in the two sides of the circumferential direction of the slit 44a. The edge portion 46 a is formed thinner than the edge portion 45 adue to the formation of an inclined face in the outer circumferentialside of a section adjacent to the slit 44 a of the valved catheter 40 athat thins gradually to the slit 44 a side. The constitution of theother sections of the valved catheter 40 a is identical to the othersections of the valved catheters 40 described above.

The operations performed employing the catheter 40 a to deliver amedical fluid into the vein of a patient A or to suction blood from avein are identical to the operations performed employing the valvedcatheter 10 as described above to deliver a medical fluid into the veinof a patient A or to suction blood from a vein. The other action andeffects afforded by the valved catheter 40 a are identical to theactions and effects of the valved catheter 40 described above.

FIG. 10 shows a cross-section of a distal end section of the valvedcatheter 50 of a fifth embodiment of the present disclosure. The valve53 of this valved catheter 50 is constituted by a linear slit 54provided to extend along the axial direction of the valved catheter 50,and by edge portions 55, 56 formed in the two sides of thecircumferential direction of the slit 54. The edge portion 55 is formedthicker than the edge portion 56 due to the formation of a projectingportion in the outer circumferential side of a section adjacent to theslit 54 of the valved catheter 50. The constitution of the othersections of the valved catheter 50 is identical to the other sections ofthe valved catheters 40 described above.

The operations performed employing the valved catheter 50 to deliver amedical fluid into the vein of a patient A or to suction blood from avein are identical to the actions performed employing the valvedcatheter 10 as described above to deliver a medical fluid into the veinof a patient A or to suction blood from a vein. Accordingly, the edgeportion 55 is formed thicker than the edge portion 56 and, as a result,deforms less readily than the latter. As a result, when either a medicalfluid flows from the interior to the exterior of the valved catheter 50or when blood flows from the exterior to the interior thereof, the edgeportion 56 deforms prior to the edge portion 55 and the slit 54 opensreadily. The other action and effects of the valved catheter 50 areidentical to the action and effects of the valved catheter 40 describedabove.

FIG. 11 shows a cross-section of a distal end section of the valvedcatheter 50 a pertaining to a modified example of the fifth embodimentof the present disclosure. The valve 53 a of this valved catheter 50 ais constituted by a linear slit 54 a provided to extend along the axialdirection of the valved catheter 50 a, and by edge portions 55 a, 56 aformed in the two sides of the circumferential direction of the slit 54a. The edge portion 55 a is formed thicker than the edge portion 56 adue to the formation of a projecting portion in the outercircumferential side of a section adjacent to the slit 54 a of thevalved catheter 50 a. The constitution of the other sections of thevalved catheter 50 a is identical to the other sections of the valvedcatheter 50 described above.

The operations performed employing this valved catheter 50 a to delivera medical fluid into the vein of a patient A or to suction blood from avein are identical to the operations performed when employing the valvedcatheter 10 as described above to deliver a medical fluid into the veinof a patient A or to suction blood from a vein. The other action andeffects afforded by the valved catheter 50 a are identical to the actionand effects afforded by the valved catheter 50 described above.

In addition, it should be understood that the valved catheter pertainingto the present disclosure is not limited to the embodiments describedabove, and that various alterations may be made thereto. For example,while the embodiments described above describe the employment of apolyurethane as the resin from which the valved catheter 10 and so on isconstituted, in addition to polyurethane, silicon, nylon orpolyvinylchloride or the like may also be employed. In addition, whilethe sections of the valved catheter 20 of the second embodimentdescribed above which are composed of a hard resin material include theedge portion 25 and the section formed along the proximal and distalends of the edge portion 25, only the edge portion 25 need be formed asa hard section. In this case, the main body of the valved catheter 20 isconstituted from three sections, that is to say, a section in which theslit 24 and the edge portion 25 are formed, and sections to the proximalside and to the distal side thereof, and these sections are connected byadhesion or fusion.

In addition, while the third embodiment described above describes theprovision of the valved catheter 30 including the contrast-impartedportion 37 in the section adjacent to the slit 34 only, thecontrast-imparted portion 37 may be formed to extend from the proximalend to the distal end of the section of the valved catheter 30 excludingthe wall portion 32. That is to say, it may be linearly formed from theproximal end to the distal end of the main body of the valved catheter30. This simplifies the manufacture of the valved catheter 30.Furthermore, while the embodiments described above describe theconnection of the port 17 to the proximal end portion 11 of the valvedcatheter 10 and so on, the proximal end portion 11 of the valvedcatheter 10 and so on may be connected to a transfusion line. Inaddition, while the embodiments described above describe the placementof the valved catheter 10 and so on in a vein, the valved catheter 10and so on may be placed in an artery in accordance with a predeterminedmethod.

Furthermore, while the embodiments described above describe the valvedcatheter 10 and so on as having a circular cross-sectional shape, thecross-sectional shape of the valved catheter 20 and so on of the secondto fifth embodiments of the valved catheter 20 and so on is not limitedto a circular shape, and they may be either elliptical in shape, oranother shape such as a square shape with curved corners, or anotherpolygonal shape. In addition, while ensuring the appropriate combinationof constituent sections of the valved catheter 10 and so on includingthe shape of the slit 14 and so on, the shape of the edge portion 15 andso on and the contrast-imparted portion 37, the provision of a pluralitythereof with respect to a single valved catheter is also possible. It issufficient, as a result, for a first edge portion to be able to bedeformed more readily than another edge portion.

1-6. (canceled)
 7. A catheter comprising: a tubular body having an openproximal end portion and a dome-shaped distal end, the tubular bodydefining a valve proximal to the distal end, the valve including a pairof edge portions defining a slit extending longitudinally along thetubular body and extending between an inner surface of the tubular bodyand an outer surface of the tubular body; and a contrast-impartingmaterial extending along an entire length of the tubular body, excludingthe dome-shaped distal end of the tubular body, wherein a portion of thecontrast imparting material is adjacent to the slit.
 8. The catheter ofclaim 7, wherein the contrast imparting material extends parallel to theslit.
 9. The catheter of claim 7, wherein the contrast impartingmaterial extends along an interior of one edge portion of the pair ofedge portions.
 10. The catheter of claim 7, wherein one edge portion ofthe pair of edge portions is adjacent to the contrast impartingmaterial, and the one edge portion adjacent to the contrast impartingmaterial is less readily deformable than the other of the pair of edgeportions.
 11. The catheter of claim 7, wherein the tubular body includesa polyurethane resin and the contrast imparting material has a hardnessgreater than the hardness of the polyurethane resin.
 12. The catheter ofclaim 11, wherein the contrast imparting material prevents thetransmission of X-rays therethrough.
 13. The catheter of claim 12,wherein the contrast imparting material is barium or tungsten.
 14. Thecatheter of claim 7, wherein the dome-shaped distal end is softer thanthe open proximal end portion of the tubular body.
 15. The catheter ofclaim 7, wherein the dome-shaped distal end is silicon or polyurethane.16. A method of delivering medical fluid to a patient, the methodcomprising: inserting a catheter into the patient's body such that aslit, defined by a pair of edge portions of a tubular body of thecatheter, is disposed in a vein; irradiating a contrast impartingmaterial adjacent to one of the pair of edge portions defining the slit;and confirming the position of a distal end section of the catheter inthe vein based on irradiation of the contrast imparting material. 17.The method of claim 16, further comprising delivering a medical fluid tothe vein through the slit.
 18. The method of claim 16, furthercomprising extracting blood from the vein through the slit.
 19. Themethod of claim 16, wherein inserting the catheter into the patient'sbody comprises making an incision in a subclavian vein of the patient,inserting the catheter into the subclavian vein, through the incision inthe subclavian vein, and passing the distal end section of the catheterinto the patient's superior caval vein.
 20. The method of claim 16,wherein the contrast imparting material extends along an entire lengthof the tubular body, excluding a dome-shaped distal end of the tubularbody.
 21. The method of claim 16, wherein the tubular body includes apolyurethane resin and the contrast imparting material has a hardnessgreater than a hardness of the polyurethane resin.